Associate Director, Toxicology US FDA Silver Spring, Maryland, United States
This talk will discuss regulatory perspectives related to the safety qualification of non-mutagenic impurities in pharmaceuticals. Qualification is the process by which safety data are generated and/or assessed for the impurity or degradation product. Relevant pharmaceutical guidance documents include the International Conference on Harmonization (ICH) M3(R2) and Q3A and B guidelines. ICH Q3A and Q3B discuss when to report, identify, and qualify impurities or degradation products in drug substances or drug products. Currently, guidance does not exist to address safety qualification in early clinical development. Examples of approaches to qualify the safety of non-mutagenic impurities and regulatory feedback will be discussed as well as recent industry proposals on the topic.
